BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21093303 · Received January 7, 2025

    Report

    Report Number
    2955842-2024-24002
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    December 10, 2024
    Report Date
    December 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE VSE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE SCRATCHES ON THE MAIN TUBE. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE INSTRUMENT WAS RETURNED WITH THE CORD CUT SO THE INSTRUMENT WAS NOT ABLE TO BE TESTED FOR SEALING/CUTTING FUNCTIONALITY. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY THROUGH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES. THE CANNULA WAS NOTED TO HAVE CHIPS ON IT, WHICH ALSO COULD HAVE CAUSED THE DAMAGE TO THE MAIN TUBE. A SEPARATE MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2025-01726) WAS SUBMITTED FOR THE CANNULA THAT WAS USED DURING THE SAME PROCEDURE. THE CANNULA ACCESSORY WAS ANALYZED AND FOUND TO HAVE SCRATCH MARK DAMAGE AT THE DISTAL END OF THE CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, THE COATING/METAL SHAVINGS ON SHAFT OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT SCRAPED OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SALES REPRESENTATIVE (CSR) THAT WAS PRESENT DURING THE PROCEDURE STATED THAT THE SURGEON WAS ABLE TO REMOVE MOST OF THE METAL SHAVINGS. IT IS UNKNOWN IF ALL THE SHAVINGS WERE RETRIEVED. A POST OPERATIVE X-RAY WAS PERFORMED BUT THE RESULTS OF THE X-RAY ARE UNKNOWN. THE SURGEON REPORTED THAT THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012166 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 L82240906 0343 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES